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Saved by the Bell: Ethics Training Rules Put on Hold

After receiving a congressional inquiry from Representative W. J. "Billy" Tauzin, the Office of Research Integrity (ORI) suspended new ethics training regulations on 20 February 2001, just months after they were announced on ORI's Web site.

As Next Wave reported in December, these rules would have required all Public Health Service-supported researchers to undergo instruction in the Responsible Conduct of Research (RCR). Tauzin's letter specifically questions the way in which the ORI solicited comments and issued the regulations. At the heart of the matter is whether ORI should have published the rules in the Federal Register, a repository of federal regulations and notices, instead of on the ORI Web site alone. In an official response to Tauzin, ORI Director Chris Pascal argues that the RCR regulations did not constitute new rules, but "[the document] was a natural extension of the pre-existing RCR requirement for NIH training grants." In other words, they should not technically be considered to be a set of new federal rules worthy of publication in the Federal Register. Comments were indeed received from numerous professional societies and institutions during the formal comment period established on the ORI site, and these comments were addressed in the final draft of the RCR policy.

But some commentators were not happy with the ultimate version of the regulations. In an interview with Next Wave, Pascal says he has continued to field criticisms, even after the final policy was posted. He notes that some parties who have contacted him favor not having a policy at all, and others point out that the rules would constitute an excessive administrative burden due to the huge increase in the cadre of scientific staff whom institutions must formally train. But some institutions are, in fact, moving forward with implementing their own ethics training programs, despite the ongoing controversy over the rules' validity.

The regulations may be under wraps for now, but Pascal is quick to emphasize that they are "not withdrawn." In the end, ORI may go ahead with the RCR policy as it stands, or revise it pending a further review of both the burden it would place on institutions and the process ORI is obliged to use to institute the regulations. The ball is now in Tauzin's court, and the official word from Pete Sheffield, spokesman for the House Energy and Commerce Committee--of which Tauzin is chair--is that "We're still evaluating the documents that were provided to the committee in addition to [Pascal's] letter." Sheffield went on to say that interviews with ORI staff, as mentioned in Tauzin's letter, have not been ruled out. When asked about the possibility of formal interviews, Pascal says the ORI "is prepared to meet with [members of Congress] ... it depends on what Congress wants."